Methods for repairing anatomical joint conditions

ABSTRACT

The present invention relates generally to minimally invasive, cost-effective, adaptable methods, systems, and devices used to repair anatomical joint conditions. The repair may be necessitated by trauma, disease or other conditions. The anatomical joint may specifically include mammalian joints such as the knee, shoulder, elbow, wrist, finger, hip, spine, toe and ankle, for example. The methods, systems, and devices disclosed herein include leveraging the significant (and often unappreciated) role the subchondral bone plays in the health status of the afflicted anatomical joint.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/778,196, which is a U.S. National Phase Application of PCTApplication No. PCT/US2016/063481, filed Nov. 23, 2016 (with publicationnumber WO 2017/091657), which claims the benefit of U.S. ProvisionalApplication No. 62/260,030, filed on Nov. 25, 2015, all of which areincorporated herein by reference in their entireties for all purposes.

BACKGROUND OF THE INVENTION

The present invention relates generally to methods, systems, and devicesfor repairing anatomical joints. The repair may be necessitated bytrauma, disease or other conditions (i.e. genetic deformity) and mayspecifically include mammalian joints such as the knee, shoulder, elbow,wrist, toe, hip, finger, spine and/or ankle, for example.

The knee is particularly susceptible to degeneration from disease,trauma, and long-term repetitive use that eventually leads to pain,swelling, and/or ankylosis. Knee pain alone is the impetus for variousmedical interventions and associated treatment costs.

Typically, the knee joint undergoes a wide range of motion and stressdaily. In a healthy knee, the articulation between the bones of the kneeis lined with cartilage. This cartilage serves to keep the knee stable,reduce joint friction, and absorb shock. Serious problems result whenthis cartilage deteriorates. In some cases, a patient may be in suchsevere pain that they cannot walk or bear weight.

Patients most often seek treatment because of pain and deterioration ofquality of life attributed to osteoarthritis. Degenerative arthritis(i.e. osteoarthritis) is a very common joint disorder affecting anestimated 21 million Americans and may be part of a cluster of diseasesknown as metabolic syndrome. The disease is characterized by cartilageloss at the joint, and symptoms generally include pain and stiffness.Osteoarthritis can affect all joints of the body. The main goal ofosteoarthritis treatment is to reduce or eliminate pain and restorenormal joint function. Both non-surgical and surgical treatments arecurrently available for this purpose, with the appropriate treatmentbeing selected based, in part, on the stage and/or severity of thedisease.

Non-surgical treatments for knee osteoarthritis may include weight loss(for the overweight patient), activity modification (low impactexercise), quadriceps strengthening, patellar taping, analgesic andanti-inflammatory medications, and injections of corticosteroids and/orviscosupplements. Non-surgical joint treatments, usually involvepharmacological intervention such as the administration of non-steroidalanti-inflammatory drugs or injection of hyaluronic acid-based products.These treatments are initially administered to patients experiencingrelatively less severe pain or joint complications. However, whennon-surgical treatments prove ineffective, or for patients with severepain or bone injury, surgical intervention is most likely required.

In addition to osteoarthritis, other conditions and diseases that impairthe integrity and function of the knee and other human joints, includearthroses, chondromalacia patella, isolated chondral defect, juvenileidiopathic arthritis, ligamentous deficiency arthroses, osteonecrosis,osteochondritis dissecans, patellar instability, post-ligamentous injuryarthritis, post-meniscectomy arthritis, post-meniscectomy arthroses,post-traumatic arthritis, septic arthritis and rheumatoid arthritis.Rheumatoid arthritis is an autoimmune disease where the body's defensivemechanisms attack the healthy joint tissue. Genetic defects can alsopredispose a person to experience joint problems.

Isolated articular cartilage defects and generalized cartilage disease,arthroses and arthritis, respectively, have certain surgical treatmentoptions which attempt to mimic or recreate normal anatomy and jointmechanics and/or relieve symptoms of discomfort, instability and pain.Isolated disease often progresses to generalized disease, or arthritis.Generalized arthritis may also develop without known prior isolateddisease. Arthritis may be present as a uni-, bi-, or tri-compartmentaldisease.

Uni-compartmental arthritis is typically less amenable to surgicaloptions used for smaller isolated articular defects. With advancedcartilage degeneration and joint space narrowing, there is typicallyincreased axial deformity and misalignment. Surgical options includeosteotomy or uni-compartmental replacement. Options for bi- ortri-compartmental arthritis are combined procedures or total kneereplacement.

Cartilage disease has been previously addressed by various means ofreplacing or substituting the damaged cartilage. Microfracture orabrasionplasty is a form of irritating exposed bone to createreplacement fibrocartilage, but the resultant material is inferior tonative cartilage.

Treating cartilage disease has also been attempted by realigning thejoint with an osteotomy. This relieves an overloaded compartment,transferring stress to a less diseased compartment. The success of thisapproach involves avoiding non-union and other complications, requiresprolonged non-weight bearing activity and requires eight to twelvemonths to realize clinical benefits. Only patients with mostlyuni-compartmental disease are candidates for this treatment. Osteotomyalso complicates latter joint replacement.

Osteochondral transplant replaces plugs of diseased cartilage andaccompanying subchondral bone with grafts from either the patient orhuman cadaver. Small discrete lesions work well, but larger lesions,bipolar disease, and diffuse disease are not well addressed by thistransplant procedure. Chondrocyte implantation harvests the patient'scartilage cells, grows them, and re-implants them on the bony bed, andcovers them with a periosteal patch. Each of the aforementionedtechniques work best for small contained lesions, unipolar defects andprimarily femoral condyle lesions. Less optimal results occur withpatellofemoral joint disease and tibial sided disease.

Surgical treatments, such as high tibial osteotomy (HTO), arthroplasty(TKA), or total knee replacement (TKR) are frequently recommended forpatients with severe pain associated with osteoarthritis, especiallywhen other non-invasive options have failed.

Arthroscopy is used to treat other causes of pain from arthritis,namely, loose bodies, loose or frayed cartilage, meniscus tears, andsynovitis. These are temporizing measures (as this author can personallyattest having undergone multiple arthroscopic surgeries).

The end stage of cartilage disease is to perform total jointreconstruction. This type of procedure presents a prolonged recoverytime and surgical risks. Because total joint prostheses are fabricatedof metal and plastic, revision surgery for worn-out components isfraught increased risk of complications compared to primary surgery.

All the aforementioned surgical procedures are relatively invasive,expensive and often only provide short term pain relief for the patient.Unfortunately, none of these procedures ameliorate all of the jointconditions and diseases discussed above.

Very little is known about the cause and progression of arthritis.Recently, with current diagnostic techniques such as MRI and bonescintigraphy, more information has been elucidated about the diseaseprocess and progression. In particular, it has been discovered that thesubchondral bone plays a significant and important role in theinitiation and progression of arthritis. The subchondral bone lies underthe articular cartilage and provides support for the cartilage of thearticular surface. Therefore, arthritis is not just a disease of thecartilage, but a disease affecting the underlying subchondral bone aswell. Most of the clinical research to date is focused on cartilageregeneration/replacement and not on the status of underlying bonehealth.

Traditionally, cartilage has been viewed to be avascular, with diffusionof nutrients occurring from within the joint. Studies have confirmed,however, that subchondral bone is a key source of vascular andnutritional support for cartilage. With age, vascular and structuralsupport from the subchondral bone diminishes, allowing arthritic diseaseto progress. The inability of the bone to adequately repair itself asincreasing damage occurs starts a cycle of further destruction,interfering with cartilage vascular supply and structural support. Thus,the patient often experiences a downward spiral of pain.

As cartilage wear occurs, the primary functions of cartilage—to providea low-friction bearing surface and to transmit stresses to theunderlying bone—are diminished.

Bone is most healthy when resisting compressive stresses. The shearstresses from the joint are partially converted to compression andtension via the architecture of the cartilage baseplate. Further, byvirtue of the ultra-low friction surface of cartilage on cartilage(which is about 20× lower friction than ice on ice), shear stresses aremostly converted to longitudinal stress. The subchondral bone is thepredominant shock absorber of joint stress. Via its arch-likelattice-work of trabecular bone, stresses are transmitted to the outercortices and ultimately dissipated. Cartilage itself providessurprisingly little shock absorption secondary to its shear thicknessand mechanical properties.

Bone is the ultimate shock absorber, with fracture being the unfortunateendpoint of force attenuation. Trabecular microfractures have been shownto occur in locations of bone stress in impulsively loaded joints. Everyjoint has a physiologic envelope of function. When this functionalenvelope is exceeded, the rate of damage exceeds the rate of repair. Ascartilage disease progresses, subchondral bone is less able to dissipatethe shear-type stresses it encounters. The attempts of subchondral boneto heal and remodel are seen as arthritis progresses includingnoticeable osteophyte formation, subchondral sclerosis, cyst formation,subchondral MRI-enhanced changes, and increased signal on bonescintigraphy. Joint deformity from these changes further increases jointreaction force. Cartilage homeostasis is compromised across structural,vascular, neural, and nutritional regions.

Clinical success of current cartilage surgery is limited as it generallyonly works for small, uni-polar (one-sided joint) lesions of the femoralcondyle. No current treatment exists for bone edema or osteonecrosis ofthe knee.

Additional information related to attempts to address these problems canbe found in U.S. Patent Numbers: U.S. RE43714; U.S. Pat. Nos. 2,188,631;4,055,862; 4,344,193; 4,431,416; 4,502,161; 4,654,314; 4,687,675;4,728,332; 4,787,848; 4,820,156; 4,880,429; 4,886,456; 4,919,667;4,963,145; 5,007,934; 5,026,373; 5,171,322; 5,176,710; 5,306,311;5,344,459; 5,514,141; 5,632,745; 5,865,849;

U.S. Pat. Nos. 5,984,970; 6,037,519; 6,042,610; 6,046,379; 6,093,204;6,149,651; 6,193,755; 6,206,927; 6,447,545; 6,530,956; 6,540,786;6,562,071; 6,629,997; 6,645,251; 6,699,252; 6,758,865; 6,761,739;6,767,369; 6,783,550; 6,793,676; 6,855,165; 6,911,044; 6,923,831;6,994,730; 7,066,961; 7,282,063; 7,291,169; 7,297,161; 7,338,524;7,585,311; 7,608,105; US 80775563; U.S. Pat. Nos. 8,317,792; 8,480,757;8,623,089; 8,608,802; 8,753,401; 8,753,401; 8,968,404; 9,155,625; andU.S. Patent Application Publication Numbers: US 20020173855; US20030040798; US 20030109928; US 2003083665; US 20040006393; US20040133275; US 20040199250; US 20040243250; US 20050004572; US20050033424; US 20050043813; US 20050055101; US 20050060037; US20050171604; US 20050209703; US 20050221703; US 20050234549; US20050267584; US 20050278025; US 20060155287; US 20060173542; US20060190078; US 20070005143; US 20070078518; US 20070179610; US20080077248; US 20080119947; US 20080215055; US 20080262616; US20090024229; US 20100145451; US 20110029081; US 20110034930; US20110125264; US 20120053588; US 20120172880; US 20130035764; US20140303629; US 20140287017; US 20140250676; US 20140276845; US20140148910; US 20140121708; US 20140114369; US 20140107795; US20140109384; US 20140277544; US 20130035561; US 20140276845; US20140039454; US 20130035764; US 20140121708; US 20120316513; US20140074103; US 20130325126; US 20140074117; US 20110125264; US20140107781; US 20110125157; US 20120316571; US 20160250026; as well asEuropean Patent Application Numbers: EP 0739631B1; EP 1541095; EP1719532A3; EP 2174674B1; EP 2308027B1; EP 2621411A2; EP 2717808A2 andInternational Patent Application Numbers: CA 2838816A1; WO 199624302A1;WO 200139694A1; WO 2007007106A1; WO 2010065426A1; WO 2011063240A1; WO2011063250A1; WO 2012170805A2; WO 2013137889A1; WO 2014145406A1; WO2014145267A1; WO 2014152533A1; WO 2014159913A1; WO 2014039998A1; WO2014053913A2; WO 2014045124A2; and WO 2014074806A1, for example.

Various methods, systems, and devices for repairing anatomical jointconditions, including some embodiments of the invention, can mitigate orreduce the effect of, or even take advantage of, some or all of thesepotential problems.

Therefore, there is a legitimate need for cost-effective, minimallyinvasive methods, systems and devices for repairing anatomical joints,including the human knee joint. The need is particularly acute insociety today given an aging population that cherishes an activelifestyle. It would be particularly desirable to have a minimallyinvasive methods, systems and devices for repairing anatomical jointsconditions that specifically address the subchondral bone in arthriticdisease process and progression to relieve the pain that results fromdiseased subchondral bone and the spectrum of symptoms that result fromarthritis, including pain, stiffness and swelling. It would be furtherdesirable to have methods, systems and devices for repairing anatomicaljoints that provide: (1) a treatment specifically for bone edema, bonebruises, and osteonecrosis that has previously not existed; (2)structural scaffolding to assist in the reparative processes of diseasedbone next to joints; (3) shock absorbing enhancement to subchondralbone; (4) compressive, tensile, and especially shear stress attenuationenhancement to subchondral bone; (5) a means to prevent further jointdeformity from subchondral bone remodeling such as osteophyte formation;(6) assistance in the healing or prevention of further destruction ofoverlying cartilage by maintaining and allowing vascularity andnutritional support from subchondral bone; (7) assistance in the healingor prevention of further destruction of overlying cartilage by providingan adequate structural base; (8) a minimally invasive alternative tototal joint reconstruction that also does not preclude or furthercomplicate joint reconstruction; (9) a treatment for subchondral bonedisease and arthritis that delays or stops disease progression; (10) animplant for arthritis that is less likely to loosen or wear, as it isintegral to the trabecular framework it supports; (11) an alternativefor tibial sided, patellofemoral, and bipolar disease (tibial-femoral)that is relatively easy to perform, as an adjunct to arthroscopy, and asan outpatient procedure with minimal downtime for the patient; (12) atreatment for arthritis that allows a higher level of activity than thatallowed after joint resurfacing or replacement; (13) a cost effectivealternative to joint replacement with reduced need for revision andsurgical morbidity, especially in countries with limited medicalresources; and (14) a treatment option in veterinary medicine,specifically in equine arthroses and arthritides, among other desirablefeatures, as described herein.

BRIEF SUMMARY OF THE INVENTION

According to one embodiment of the present invention, an implantableorthopedic device for repairing anatomical joints and ameliorating jointconditions at a treatment site of a human or animal (i.e. equine, ovineor bovine) comprises a first section with a joint-ward end, an opposingmating end, and a lateral wall extending between the joint-ward end andthe mating end. The first section further comprises a peripheral columnpartially forming the lateral wall of the first section and a centralcolumn at least partially within the peripheral column. The joint-wardend comprises a plurality of fenestrations. Each fenestration is formedby a confluence of the peripheral column and the central column. Thefirst section further comprises a central aperture within and formed bythe central column and configured to mate with an introducer. A secondsection comprises a mating end, an opposing leading end, and a lateralwall extending between the mating end and the leading end. The lateralwall has an inner wall and an outer wall. The lateral wall of the secondsection comprises protrusions on the inner wall, outer wall, or acombination of both the inner and outer walls. The leading end comprisesan edge that first penetrates a bone during implantation. The lateralwall of the second section further comprises a plurality offenestrations between the protrusions. The device has a width and alength and the width and length of the device comprise an aspect ratioof between about 0.3 and 3.0, respectively. More specifically, the widthand the length of the device may comprise an aspect ratio of betweenabout 0.3 and 2.0, respectively. The implantable orthopedic device isimplanted in the bone at the treatment site and the bone is asubchondral bone.

In some embodiments, the implantable orthopedic device may include abiomaterial. The biomaterial is a biocompatible material, a biocompositematerial, a biomimetic material, a bioactive material, a nanomaterial, apartially absorbable material, a fully absorbable material, a tissueforming material, a biphasic material, a replaceable material, a graftmaterial (e.g. an allograft, autograft, or xenograft) or any combinationof these materials. The biphasic material may include a solid componentand non-solid component. In some embodiments, the non-solid component isa gel. The gel has an elastomeric quality and a viscosity in order tosufficiently inhibit the it from dripping off the device when the deviceis implanted at the treatment site. The viscosity is greater than about1.0 mPa-s (i.e. millipascal seconds). Preferably, the viscosity isbetween about 1.5 mPa-s and 5.0 mPa-s. The gel is generally similar tothe consistency of a Haribo Gummibärchen (i.e. gummy bear fruit candy),for example. The non-solid component of the biphasic material exhibitsviscoelastic properties. The biomaterial includes an antimicrobial agentand/or a chemotherapeutic agent.

In some embodiments, the anatomical joint may include a mammalian hip,knee, ankle, shoulder, elbow, wrist, finger, toe, or spine per someembodiments of the subject invention. The anatomical joint is selectedfrom the group consisting of an acetabulofemoral joint, anacromioclavicular joint, a femoropatellar joint, a femorotibial joint, aglenohumeral joint, a humeroradial joint, a humeroulnar joint, aninterphalangeal joint, a metacarpal joint, a radioulnar joint and atalocrural joint. In some cases, the anatomical joint is a human kneejoint. The condition is chosen from the group consisting ofchondromalacia patella, isolated chondral defect, juvenile idiopathicarthritis, ligamentous deficiency arthroses, osteonecrosis,osteoarthritis, osteochondritis dissecans, patellar instability,post-ligamentous injury arthritis, post-meniscectomy arthritis,post-meniscectomy arthroses, post-traumatic arthritis, septic arthritis,rheumatoid arthritis, osteochondral defect, subchondral boneinsufficiency, fracture, overload or genetic defects. The term“overload” in this use implies a pre-fracture state. The plurality offenestrations (i.e. perforations, openings or pores) are variable sizes(and shapes) that provide support for different tissue types and alsopromote healing repair at the treatment site. For example, the pluralityof fenestrations between the protrusions on the second section of thelateral wall are between about 300 microns and 1200 microns in size topromote bone growth while the plurality of fenestrations on thejoint-ward end of the first section are between about 100 microns to 800microns in size to promote cartilage growth. Preferably, the pluralityof fenestrations on the joint-ward end of the first section are betweenabout 400 microns to 800 microns in size to promote cartilage growth.Circular pores, pie-shaped fenestrations and other shapes areconsidered. The plurality of fenestrations are pores sized about 400microns in diameter to promote bone growth and pores sized about 200microns in diameter to promote cartilage growth.

In other embodiments, an external surface of the device is at leastpartially textured to increase the surface area of the device. Thetexture may include a dimpled pattern or even relatively more complex“patterns within a pattern” configurations. The external surface is atleast partially coated with a material and the material coating may be abiomaterial that promotes tissue growth, tissue differentiation and/ortissue attraction, for example. The material coating is selectivelyapplied to create a region of relatively thick coating and a region ofrelatively thin coating on the external surface of the device. Thematerial coating may be sprayed on the external surface of the device,bonded to the external surface of the device or deposited on theexternal surface of the device. The many ways to coat surfaces are wellknown to those of skill in the art and may include chemical orelectrochemical bonding, spray coating, vapor deposition, roll-to-rollcoating and many other methods, for example.

In some embodiments of the invention, the lateral wall of the secondsection includes one or more vascular grooves extending from the matingend to the leading end. The one or more vascular grooves provide asurface area for blood adhesion and may extend in an substantiallyparallel configuration to encourage blood flow capillarity anddiscourage blood flow turbulence. Alternatively or additionally, the oneor more vascular grooves may extend in an substantially spring-shaped(i.e. coiled) configuration to encourage blood flow capillarity anddiscourage blood flow turbulence. In some embodiments, the device isconfigured for customized production, the customized device correspondsto a specific joint anatomy to accommodate bipolar defects orgender-specific differences, for example. The device may even beproduced in a customized fashion using additive manufacturing (AM),direct metal laser sintering (DMLS), selective laser sintering (SLS),selective laser melting (SLM), metal injection molding (MIM), laserengineered net shaping (LENS), 3D printing, or computer-aideddesign/computer-aided manufacturing (CAD/CAM) techniques, for examples.Of course, other production methods are contemplated and are not limitedto the examples previously provided. The customized device may be amonobloc device or a modular device and may be configured to accept andretain an amount of the biomaterial when the biomaterial is administeredpost-implantation. The amount of biomaterial administeredpost-implantation may be made with a needle injection, a fluoroscopeguide, or an ultrasound guide. A carrier substance may be attached tothe device. The carrier substance is a polymer, or biomaterial, ormedicine, or a hybrid combination thereof. The carrier substance may bea polymer configured in a sponge matrix arrangement. The carriersubstance may be a biomaterial that includes cartilage, osteocartilage,platelet-rich plasma (PRP), a chemotactic substance or a cellulardifferentiation substance. The cartilage or other tissue may be anautograft, allograft or xenograft. The carrier substance may alsoinclude an artificial graft with a synthetic material, for example. Thecellular differentiation substance may include stem cells, specificallyincluding but not limited to, injectable mesenchymal stem cells (MSCs)that are configured to migrate to the device when the device isimplanted at the treatment site. Further, the biomaterial may becontained by a cover.

In some embodiments, the lateral wall of the second section has a taperfrom the mating end to the leading end and the taper is a variableconfiguration or an adjustable configuration. The outer wall of thelateral wall of the second section has a taper of between about 1.0degree and 9.0 degrees from the mating end to the leading end and theinner wall of the lateral wall of the second section has a taper ofbetween about 1.0 degree and 9.0 degrees from the mating end to theleading end. The protrusions on the inner wall and the protrusions onthe outer wall are both configured to engage bone when the device isimplanted at a treatment site. The protrusions may be threads includinga variable thread pitch design or a consistent thread pitch design. Thethreads may be chosen from the group consisting of reverse cuttingthreads, notched threads, tapered threads, buttress threads, metricthreads, trapezoidal threads, acme threads, pipe straight threads,unified threads, custom threads and multi-threads, for example. Thetapered threads are configured to constantly purchase new bone tominimize strip out and increase holding power at the treatment site.

In another embodiment, the device further comprises at least threestruts with each strut extending between and connecting the peripheralcolumn and the central column. Each strut supports the central column.The struts may be between the pie-shaped fenestrations, for example. Thethree or more struts may include one or more flares extending below theat least three struts. The flare(s) are configured to resist subsidencewithin the bone at the treatment site. It is understood that the atleast one flare may be a tapered flare, a helical flare, a notched flareor a barbed flare configuration. The helical flare may include an angleof more than 45 degrees and the flare is configured to self-lock. Themating end of the second section includes a non-threaded press-fitportion configured to substantially seal out synovial fluid. The devicemay also include a geometric washer attached to the joint-ward end ofthe first section. The washer geometry comprises a convex, concave orflat profile as seen on a cross-sectional, lateral perspective view.Additionally, the washer geometry is configured in a bowl-shape tocontain a biomaterial and promote tissue ingrowth at the treatment site.The biomaterial may comprises a porous material impregnated with amatrix-promoting substance and the substance may support a population ofprogenitor cells.

The washer geometry may include chambers to house a biomaterial andengage a tissue at the treatment site. The chambers may have anoverhanging lip portion configured to retain the biomaterial.Furthermore, the washer geometry may be independently customized andconfigured to match a topography of the bone at the treatment site. Thishas several advantages including facilitating smooth joint movementpost-implantation. The attachable washer includes a threaded attachment,a spiked attachment, a slide-lock attachment, a snap-fit attachment or anotched attachment, for example. The washer may be partially orcompletely absorbable over a period of time after the washer is attachedto the device at the treatment site. The washer may also be configuredto promote guided tissue regeneration (GTR).

In another embodiment of the subject invention, a method of repairinganatomical joints and ameliorating joint conditions comprises providingat least one non-telescoping, single walled primary bearing strutelement of variable geometry and thickness having a longitudinal bodywith open opposing ends and a vertically disposed inner edge and avertically disposed outer edge suitable for insertion within asubchondral bone. The vertically disposed outer edge is aligned to fitthe subchondral bone at the treatment site. A plurality ofvertically-formed hollow grooves are disposed on the outer edge andengaged with a longitudinal insertion holder. The longitudinal insertionholder is used to penetrate the subchondral bone during insertion of theat least one non-telescoping, single walled primary bearing strutelement within the subchondral bone at the treatment site. The at leastone non-telescoping, single walled primary bearing strut element ismaintained in place within the subchondral bone by aligning thevertically disposed inner edge to first penetrate the subchondral boneduring insertion. A porosity of the longitudinal body is positioned atthe treatment site to promote healing by vascularity, bridging bone, andother biological elements that pass through the porous body.

In yet another embodiment, a method of preparing a defect at a treatmentsite on a subchondral bone to repair an anatomical joint and amelioratea joint condition comprises surgically accessing the treatment site. Asizing instrument with a proximal end, a distal end, and a cylindricalmember disposed between the proximal end and the distal end is accessed.The cylindrical member has a lumen for receiving a guidewire. The distalend of the sizing instrument is centered in a position over the defectat the treatment site on the subchondral bone. The distal end hasconcentric rings and each ring has a known diameter. A diameter of thedefect is measured by comparing the defect diameter with the closestcorresponding known diameter on the sizing instrument. The guidewire isinserted through the lumen of the cylindrical member while the distalend of the sizing instrument is centrally positioned over the defect.The subchondral bone is contacted with a distal end of the guidewire.The center of the defect is marked by reversibly attaching the guidewireto the subchondral bone. The sizing instrument is then removed over theguidewire. A countersink instrument having a diameter substantiallymatching the measured diameter of the defect is selected. Thecountersink is positioned over the guidewire. The countersink issimultaneously rotated and lowered to engage a soft tissue and thesubchondral bone. The subchondral bone is penetrated with thecountersink to form a hole. The hole has a first depth. The countersinkis removed over the guidewire. A cannulated drill is positioned over theguidewire. An inner circular portion of the subchondral bone is nowremoved while preserving a central post of subchondral bone in ansubstantially undisturbed native state by simultaneously rotating andlowering the cannulated drill into a center of the countersink hole. Theinner circular portion has a second depth. The cannulated drill isremoved over the guidewire. The guidewire is detached from thesubchondral bone and the guidewire is removed from the treatment site.An implantable orthopedic device is placed in the hole over a top of thecentral post. The central post is accepted by a hollow central column ofthe device when implanted. The orthopedic device is secured into thehole using a driver instrument and the driver instrument is removedleaving the orthopedic device secured in place. This method may furthercomprise the step of providing an inflatable envelope, inserting theinflatable envelope into the anatomical joint in a collapsed positionand at least partially expanding the envelope to an inflated position tocause surrounding tissue to be displaced by an inflation pressure. Inthis manner, the treatment site may be more easily accessed and viewedby the surgeon because tissues in the vicinity of the treatment site areretracted (i.e. displaced) as the envelope inflates. The hollow centralcolumn of the implantable orthopedic device may include a chamfer. Thechamfer narrows a diameter of the hollow central column to compact thecentral post of the subchondral bone when the implantable orthopedicdevice is placed in the hole over the top of the central post. Thechamfer includes an angle of about 45 degrees. The loading of thecentral post is increased and/or resorption of the central post isdecreased when the central post of the subchondral bone is compacted.The chamfer inhibits formation of bone cysts and/or bone spurs. Theimplantable orthopedic device includes a blind-ended central aperturewhich extends only partially through a joint-ward end of the device suchthat synovia (i.e. synovial fluid) leakage is mitigated or evenprevented.

The first depth, as previously described, allows the implantableorthopedic device to be implanted substantially flush with (or slightlybelow) a surface of the subchondral bone. The second depth promotesblood flow around the top and sides of the central post to facilitaterepair of the anatomical joint at the treatment site. The central postof subchondral bone is preserved in an substantially undisturbed stateto provide structural integrity to the treatment site and facilitaterepair of the anatomical joint. The inner portion has a diameter lessthan or equal to the diameter of the countersink hole and the innerportion has a diameter larger than a diameter of a wall of theimplantable orthopedic device. The inner portion has a second depthsufficient to allow placement of the implantable orthopedic device.

Furthermore, the countersink instrument comprises two or more blades andthe blades are equally spaced apart from one another. The blades arearranged circumferentially about a central axis. In some embodiments,the countersink instrument comprises four blades with each bladeoriented at 180 degrees relative to the adjacent blade. The cannulateddrill comprises two or more prongs and each prong is equally spacedapart from one another. In other embodiments, the cannulated drillcomprises three prongs and the prongs are configured to debride andclear bone away during use to preserve a porosity of the bone, minimizetissue trauma, encourage bleeding, and promote healing at the treatmentsite. Each blade is configured with a radius of curvature thatsubstantially mirrors a radius of curvature of the subchondral bone atthe treatment site. The radius of curvature of the subchondral bone atthe treatment site may be convex, concave or even flat (i.e. 180degrees).

Some minor bleeding during this procedure is beneficial to promotehealing. The bleeding includes laminar blood flow, turbulent blood flow,capillary blood flow and percolatory blood flow. The orthopedic deviceis secured in the hole using the driver instrument and further comprisesengaging a distal end of the driver instrument with a joint-ward end ofa first section of the orthopedic device and screwing the orthopedicdevice into the hole. This method my also further include creating oneor more vascular channels in the subchondral bone at the treatment siteto facilitate additional minor bleeding. These vascular channels arecreated after the step of removing the countersink over the guidewire.The vascular channels are created by drilling, reaming, tapping, boring,or poking, for example. Of course other ways to create vascular channelsand micro channels are contemplated.

The second depth is greater than the length of the implantableorthopedic device. The distal end of the driver instrument reversiblyengages a joint-ward end of the device to move the orthopedic deviceinto the hole. The step of moving the orthopedic device into the holemay further comprise locking the device in the hole at a depth where thejoint-ward end of the device is substantially flush with a surface ofthe subchondral bone. The orthopedic device is locked via a morselocking tapered connection. The treatment site may be accessed from avariety of directions using different surgical techniques. For example,an antegrade insertion technique may be used to access the site throughthe joint surface from below. The treatment site may also be accessedfrom either side using a peripheral insertion technique. Alternatively,the treatment site may be surgically accessed using a retrogradeinsertion technique whereby the treatment site or joint compartment isaccessed in a direction opposite antegrade. Retrograde, antegrade andperipheral insertion techniques are well known to those of ordinaryskill in the art including orthopedic surgeons, for example. Theimplantable orthopedic device may be covered with a protective sleevebefore the device is introduced into a patient and the sleeve may beremoved before the device is positioned in the hole over a top of thecentral post.

In another embodiment of the invention, a cannula is disclosed toarthroscopically retract a target tissue at an anatomical joint. Thecannula comprises a delivery tube having a distal end, a proximal end,and an elongate member disposed between the distal and proximal ends. Aguided slot runs at least partially along a length of the elongatemember. A rod-like retractor is configured for movable insertion in thedelivery tube. The retractor has a distal end, a proximal end, and anelongate section disposed between the distal and proximal ends. Thedistal end of the retractor is bent at an angle relative to the elongatesection of the retractor. In use, the distal end of the retractor isconfigured to movably track along the slot and engage the target tissue.The engaged tissue is retracted in an substantially proximal directionrelative to an axis of the delivery tube when a force is applied to theproximal end of the retractor. The retractor can be locked at a positionalong the slot. The cannula may have an angle of about 90 degrees. Thedelivery tube of the cannula may be composed of a transparent materialsuch as clear plastic, for example. The cannula may be configured toextend telescopically and may not be straight. The cannula is capable ofretaining a reversibly customized configuration. The customizedconfiguration is accomplished by the application of one or moredirectional forces along the delivery tube (e.g. such as bending a shapememory material). The retractor may include an inflatable balloon whichinflates around at least part of a cross-sectional circumference of thecannula. The cannula further includes one or more modular leaflets. Thecannula is bendable so as to facilitate navigation along a tortuousanatomical path.

In yet another embodiment, a method for retracting a tissue of ananatomical joint disclosed. The joint has a targeted space, the methodcomprises surgically accessing the anatomical joint. An inflatableenvelope is arthroscopically inserted in the targeted space in a firstcollapsed position and the inflatable envelope is at least partiallyexpanded into a second inflated position to cause the surrounding tissueto be displaced by an inflation pressure. The envelope is inflated witha gas or liquid. If a liquid is used to inflate the envelope, a salinesolution may be used. Of course, many other substances can also be usedto safely and efficiently inflate the envelope.

In other embodiments; the anatomical joint is a human knee joint and thetargeted space is a suprapatellar pouch or a retropatellar pouch. Thedisplaced tissue may be cartilage, ligament, tendon, and/or adiposetissue, for example. The inflatable envelope is foldable in thecollapsed position and may also be deflated and subsequently removedfrom the targeted space.

In another embodiment, a method for delivering at least one therapeuticbiomaterial to a primary treatment site to repair an anatomical jointcomprises accessing an implantable orthopedic device. The deviceincludes multiple portions with each portion having a different surfacearea. A first biomaterial is applied to at least a first portion of theorthopedic device and the device is implanted at the primary treatmentsite where the biomaterial promotes repair of the anatomical joint. Aportion of the biomaterial may migrate away from the primary treatmentsite into the surrounding joint compartment to provide therapy to asecondary site beyond, and in addition to, the primary treatment site.The secondary site may be a medullary canal, for example. A secondbiomaterial is applied to at least a second portion of the device. Thesecond biomaterial and the at least second portion are different fromthe first biomaterial and the at least first portion of the device. Atleast one therapeutic biomaterial may be a biocompatible material, abiocomposite material, a biomimetic material, a bioactive material, ananomaterial, a partially absorbable material, a fully absorbablematerial, a tissue forming material, a biphasic material, a replaceablematerial, a graft material (e.g. an allograft, autograft, or xenograft)or any combination of the aforementioned materials. At least onetherapeutic biomaterial is applied to the at least first portion of thedevice after the orthopedic device is implanted at the treatment site.At least one therapeutic biomaterial is applied to the at least firstportion of the device both before and after the orthopedic device isimplanted at the treatment site. Also, at least one therapeuticbiomaterial promotes tissue growth, encourages bleeding and inhibitsinfection so as to facilitate repair of the anatomical joint. The atleast one biomaterial also possess chemotactic, cellular homing,biological crosstalk and/or time-release capabilities. In someembodiments, the at least first and/or the at least second portions ofthe device include pores, scaffolds, lattices, matrices, or anycombination thereof and the different surface areas of each portioncorrespond to a property of the at least one biomaterial.

In another embodiment of the invention, a kit for repairing ananatomical joint is disclosed. The kit comprises the implantableorthopedic device, a sizing instrument, a guidewire, a countersinkinstrument, a cannulated drill, a drill bit guide, a drill bit, asleeve, a driver instrument, an injector, an inflatable envelope, atleast one biomaterial, instructions for use, and a package. The packageholds the implantable orthopedic device as previously described, thesizing instrument, the guidewire, the countersink instrument, thecannulated drill, the drill bit guide, the drill, the sleeve, the driverinstrument, the injector, the inflatable envelope, at least onebiomaterial, and the instructions for using the kit. In someembodiments, the kit is sterilizable.

In another embodiment of the invention, a method of securing a carriersubstance to a bone defect comprises positioning a first implantableorthopedic device substantially near the bone detect. The devicecomprises a joint-ward end, an opposing mating end, and a lateral wallextending between the joint-ward end and the mating end. The lateralwall includes fenestrations. A length of strand material is provided andthe strand has first and second ends. The first end is threaded througha first fenestration. The first end exits through a second fenestration.The first end is then secured to the device. A first carrier substanceis placed substantially near, or in contact with, the joint-ward end ofthe device. The carrier substance has therapeutic properties. The secondend of strand material is looped across the carrier substance. Thesecond end is threaded through a third fenestration which is opposite,or adjacent to, the first fenestration. The second end exits through afourth fenestration. The second end of the length of strand material ispulled taut across the carrier substance and the second end to thedevice is secured to tether the carrier substance near the joint-wardend of the device. The first end and the second end may be secured tothe device by tying a knot at each end, for example. The strand materialmay comprise absorbable sutures or non-absorbable sutures and thecarrier substance and/or one or more strands may be secured either pre-or post-implantation of the device. Additional lengths of strandmaterial are used to form patterns to tether the carrier substance nearthe joint-ward end of the device.

In yet another embodiment of the invention, a method of attaching acarrier substance to a bone defect comprises positioning a firstimplantable orthopedic device substantially near the bone defect at afirst location. A second implantable orthopedic device is positionedsubstantially near the bone defect at a second location. It should benoted that the first and second locations are different locations. Eachof the first and second devices comprises a joint-ward end, an opposingmating end, and a lateral wall extending between the joint-ward end andthe manna end. A carrier substance is placed substantially near, or indirect contact with, the joint-ward end of the first and second devices.The carrier substance spans a contiguous area between the first andsecond devices across the bone defect. A length of strand material isprovided and the material has a first end and a second end. The firstend is threaded through a first fenestration in the first device. Thefirst end exits through a second fenestration in the first device. Thefirst end is secured to the first device. The second end of a strandmaterial is looped across the carrier substance. The second end isthreaded through a first fenestration in the second device. The secondend exits through a second fenestration in the second device. The secondend of the length of suture material is pulled taut across the carriersubstance. The second end is secured to the second device so as totether the carrier substance between the devices. The lateral wall mayinclude threads for anchoring the device in a bone and, if the lateralwall contains threads, the threads include notches spaced along a threadpath. The fenestrations are vertically aligned under each of thenotches. The carrier substance comprises a polymer, or biomaterial, ormedicine, or a combination thereof. The fenestrations may be verticallyaligned with each other along the lateral wall.

In another embodiment, a driver instrument for reversibly engaging animplantable orthopedic device is disclosed. The device is configured toimplant in a bone. The driver instrument comprises a distal end having amale configuration including a centrally-located threaded protuberanceand relatively shorter elongate knobs. The knobs form a diameter aroundthe protuberance such that when the driver instrument is aligned inproximity with the implantable device and rotated, the threadedprotuberance engages a mirror reverse female configuration located on ajoint-ward end of the implantable device. Continued rotation causes theknobs to engage the corresponding configuration on the implantabledevice to provide sufficient leverage to implant the implantableorthopedic device in the bone.

In yet another embodiment, an extraction tool is disclosed for removingan implantable orthopedic device implanted in a bone. The extractiontool comprises a distal end, a proximal end and an elongate memberdisposed between the distal end and the proximal end. The elongatemember includes a conduit running at least along a length of the distalend. The conduit includes two or more nubs projecting from an insidesurface of the conduit. The nubs are configured to engage and slide pastcorresponding notches spaced vertically along thread paths of theimplantable orthopedic device when the extraction tool is placed over anexposed surface of the implantable orthopedic device. The extractiontool is rotated after the two or more nubs engage and slide past atleast one of the corresponding notches to seat the notches betweenthread paths. This allows efficient leverage using a twisting and/orpulling motion to remove the device from the bone. The nubs on theinside surface of the conduit are about 0.9 mm in length.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects and advantages of the presentinvention will become better understood with regard to the followingdescription, appended claims, and accompanying figures where:

FIGS. 1Aa, 1Ab, 1B and 1C are side views of embodiments of a device forrepairing anatomical joint conditions according to the presentinvention;

FIG. 1D is a side perspective view of embodiments of a device forrepairing anatomical joint conditions according to the presentinvention;

FIGS. 2A, 2B, 2C and 2D are top, lateral perspective views of otherembodiments of a device for repairing anatomical joint conditionsaccording to the present invention;

FIG. 3 is an exploded, top, lateral perspective view of the embodimentof the device for repairing anatomical joint conditions shown in FIG.1Aa;

FIGS. 4A, 4B, 4C and 4D are top perspective views of embodiments of thedevice for repairing anatomical joint conditions shown in FIGS. 1Aa, 1B,1C and 1D, respectively;

FIG. 5 is a bottom perspective view of the embodiment of the device forrepairing anatomical joint conditions shown in FIG. 1Aa;

FIG. 6 is a top perspective view of an embodiment of the device forrepairing anatomical joint conditions shown in FIG. 2A;

FIGS. 7 and 8 are top perspective views of embodiments of the device forrepairing anatomical joint conditions;

FIG. 9A is a cross-sectional, side view of the embodiment of the devicefor repairing anatomical joint conditions shown in FIG. 1A taken alongline 9-9;

FIG. 9B is a cross-sectional, side view of the embodiment of the devicefor repairing anatomical joint conditions shown in FIG. 1B taken alongline 9-9;

FIG. 9C is a cross-sectional, side view of the embodiment of the devicefor repairing anatomical joint conditions shown in FIG. 1C taken alongline 9-9;

FIG. 9D is a cross-sectional, side view of another embodiment of thedevice for repairing anatomical joint conditions according to thepresent invention;

FIG. 10 is a cross-sectional, side view of another embodiment of thedevice for repairing anatomical joint conditions according to thepresent invention;

FIG. 11A is a side view of an embodiment of a device for repairinganatomical joint conditions according to the present invention;

FIGS. 11B-11D are lateral perspective views of alternative embodimentsaccording to the present invention;

FIG. 11E is a lateral perspective view of an embodiment of a device forrepairing anatomical joint conditions according to the presentinvention;

FIG. 11F is a top view of another embodiment of a device for repairinganatomical joint conditions according to the present invention;

FIG. 11G is a lateral perspective view of another embodiment of a devicefor repairing anatomical joint conditions according to the presentinvention;

FIGS. 11Ha-11Hc are lateral perspective views of alternative embodimentsaccording to the present invention;

FIGS. 11Hd-11Hi are top views of FIG. 4D with alternative embodimentsaccording to the present invention;

FIGS. 11Hj-11Hl are top views of FIG. 4D with alternative embodimentsaccording to the present invention;

FIG. 11Hm is a lateral perspective view of an alternative embodimentaccording to the present invention;

FIGS. 12A-12B are lateral views of an embodiment according to thepresent invention;

FIGS. 13A-13B are top perspective views of embodiments according to thepresent invention;

FIGS. 13C-13D are lateral perspective views of yet additionalembodiments of a device for repairing anatomical joint conditionsaccording to the present invention;

FIG. 14A is a top perspective view of an embodiment of a device forrepairing anatomical joint conditions according to the presentinvention;

FIG. 14B is a side view of an embodiment of a device for repairinganatomical joint conditions according to the present invention;

FIG. 15A (presented in subparts 15Aa and 15Ab on separate sheets) is aflow chart diagram of an embodiment of a method for repairing anatomicaljoint conditions according to the present invention;

FIG. 15B is a cross section diagram depicting an embodiment of a methodfor repairing anatomical joint conditions according to the presentinvention;

FIG. 16A through FIG. 16V are schematic depictions of some steps of amethod for repairing anatomical joint conditions according to thepresent invention;

FIGS. 17A-17C are cross section diagrams showing embodiments of a devicefor repairing anatomical joint conditions according to the presentinvention;

FIGS. 17D-17E are lateral perspective views of other embodiments of thepresent invention;

FIG. 17Fa is an cross section view of the distal end of a cannulaaccording to other embodiments of the present invention;

FIGS. 17Fb-17H are lateral perspective views of other embodiments of thepresent invention;

FIG. 18A is a lateral perspective view of an embodiment of the presentinvention;

FIGS. 18B-18D are top perspective views of an embodiment of a device forrepairing anatomical joint conditions according to the presentinvention;

FIG. 19A is a side view perspective of a human knee joint showing anembodiment of the present invention;

FIGS. 19B-19C are perspective views of an embodiment of a device forrepairing anatomical joint conditions according to the presentinvention;

FIGS. 20A-20B and 20D are perspectives views of a countersink instrumentper another embodiment of a device for repairing anatomical jointconditions according to the present invention;

FIG. 20C is a bottom perspective view of a countersink instrument shownin FIGS. 39A-39B and 39D;

FIG. 20E is a perspective view of a countersink hole prepared in boneusing the instrument in FIGS. 20A-20D.

FIG. 20F is a cross section of a countersink hole prepared in bone usingthe instrument in FIGS. 20A-20D.

FIG. 21A is a perspective view of an embodiment of a cannulated drillfor repairing anatomical joint conditions according to the presentinvention;

FIG. 21B is a perspective view of another embodiment of a cannulateddrill as another embodiment of a device for repairing anatomical jointconditions according to the present invention;

FIG. 21C is a perspective view of yet another embodiment of a cannulateddrill for repairing anatomical joint conditions according to the presentinvention.

FIG. 21D is a perspective view of a hole and post prepared in bone usingthe instruments embodied in FIGS. 21A-21C.

FIG. 21E is a cross section of a hole and post prepared in bone usingthe instruments embodied in FIGS. 21A-21C.

FIGS. 22A and 22B are perspective views of a protective sleeve forcovering the implantable orthopedic device according to embodiments ofthe present invention.

FIGS. 23A-23C are perspective sequential views of a driver instrumentand implantable orthopedic device according to embodiments of thepresent invention.

FIG. 24A is a cut-a-way side view of an extraction tool engaged with animplantable orthopedic device according to embodiments of the presentinvention.

FIG. 24B is a perspective view of an extraction tool and an implantableorthopedic device according to embodiments of the present invention.

FIG. 24C is a side view of FIG. 24B after further engagement of theextraction tool with an implantable orthopedic device according toembodiments of the present invention.

FIGS. 25A-25B are sequential perspective views of an extraction tool andan implantable orthopedic device according to embodiments of the presentinvention.

FIG. 26 is a cut-a-way perspective view from inside the extraction toolas it is placed over an exposed surface of the implantable orthopedicdevice according to embodiments of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

According to one embodiment of the present invention there is provided adevice for repairing anatomical joint conditions and ameliorating jointconditions. According to another embodiment of the present invention,there is provided a method for repairing anatomical joints andameliorating a joint condition so, preparing a defect at a treatmentsite on a bone to repair an anatomical joint, a cannula for retracting atarget tissue, a method for delivering at least one biomaterial to aprimary treatment site, and a kit for repairing an anatomical joint. Inone embodiment, the method comprises providing a device according to thepresent invention. These embodiments will now be described in detail.

As used in this disclosure, except where the context requires otherwise,the term “comprise” and variations of the term, such as “comprising,”“comprises” and “comprised” are not intended to exclude other additives,components, integers or steps.

As used in this disclosure, except where the context requires otherwise,the method steps disclosed and shown are not intended to be limiting norare they intended to indicate that each step is essential to the methodor that each step must occur in the order disclosed but instead areexemplary steps only.

All dimensions specified in this disclosure are by way of example onlyand are not intended to be limiting, except where the context requiresotherwise. Further, the proportions shown in these Figures are notnecessarily to scale. As will be understood by those with skill in theart with reference to this disclosure, the actual dimensions andproportions of any device or part of a device disclosed in thisdisclosure will be determined by its intended use.

This application is related to U.S. Patent Application Serial Nos.13/421,792, now U.S. Pat. No. 8,968,404, entitled Method and Device forAmeliorating Joint Conditions and Diseases, filed Mar. 15, 2012, thecontents of which are incorporated in this disclosure by reference intheir entirety. This application is also related to U.S. patentapplication Ser. No. 13/420,825 now issued as U.S. Pat. No. 8,753,401,entitled Joint Support and Subchondral Support System, filed Mar. 15,2013, the contents of which are incorporated in this disclosure in theirentirety.

According to one embodiment of the present invention, there is providedmethods, systems and devices for repairing anatomical joint conditions.As per FIGS. 1Aa, 2A, and 3 , the device 10 comprises a first section 12and a second section 14, and comprises a generally cylindrical shapepartially or completely closed at one end. The first section 12 andsecond section 14 may be separately attachable (i.e., threaded orpress-fit) or fused together. The device 10 further comprises an axiallength (aa). The axial length (aa) is between about 5 mm and 30 mm (FIG.1Aa). The device may be a single section as shown in FIG. 1B, 1C or 1D.The axial length (aa) may be between 8 mm and 16 mm. Preferably, theaxial length (aa) is 8 mm (FIG. 9B) or 14 mm (FIG. 9C).

The first section 12 of the device 10 comprises a joint-ward end 16, anopposing mating end 18, and a lateral wall 20 extending between thejoint-ward end 16 and the mating end 18. The first section 12 furthercomprises a diameter (dd) and an axial length (bb). The diameter (dd) isbetween 5 mm and 30 mm (FIG. 4A). In another embodiment, the diameter(dd) is between 6 mm (FIG. 4B) and 16 mm (FIG. 4C). In one embodiment,the device may be tapered so the diameter (dd) is different thandiameter (dd′). FIGS. 9B and 9C show a taper of 6 mm and 16 mm (dd) to 5mm and 14 mm (dd′), respectively, for example. In one embodiment, theaxial length (bb) is between 0.5 mm and 2.5 mm (FIG. 1Aa). Preferably,the axial length (bb) is between about 1 mm and 2.5 mm. The axial length(bb) to the start of the first thread 46 is shown as distance (ee). Thedistance (ee) is about 2.45 mm (FIG. 9B) and about 4 mm (FIG. 9C), forexample.

In one embodiment, the first section 12 further comprises a peripheralcolumn 22 partially forming the lateral wall 20, a central column 24,and three or more than three struts 26, each strut 26 extending betweenand connecting the peripheral column 22 and the central column 24, andeach strut 26 thereby supporting the central column 24.

In one embodiment, the joint-ward end 16 further comprises a pluralityof fenestrations 28, where each fenestration 28 is formed by aconfluence of the peripheral column 22, the central column 24, and twoadjacent struts 26 of the three or more than three struts 26. Eachfenestration 28 can comprise any shape suitable for the intended purposeof the device 10, as will be understood by those with skill in the artwith respect to this disclosure. In one embodiment, as shownparticularly in FIGS. 2A and 4A, each fenestration 28 comprises a pearor teardrop shape. In another embodiment, as shown in FIGS. 2B, 2C, 2D,4B, 4C and 4D, each fenestration 28 comprises circular pores. As will beunderstood by those with skill in the art with respect to thisdisclosure, all fenestrations 28 on the device 10 can comprise the samesize and shape or one or more than one fenestration 28 can comprise adifferent size, different shape or both a different size and a differentshape than one or more than one other fenestration 28. The fenestrationscan also be arranged in a “pattern 701, 801 within a pattern 702, 802”configuration as shown in FIGS. 7 and 8 , respectively. This arrangementmay also include fractal and/or undulating surface geometries. Ofcourse, a plethora of other patterns are possible.

The fenestrations may have different porosities targeted to promotespecific tissue growth and differentiation. For example, fenestrationsof about 300-1200 microns in diameter may promote existing bone growthand/or regrow bone (particularly along the sides of the device) whilefenestrations of about 400-800 microns may be best suited to promoteexisting cartilage growth, regrow cartilage and/or prevent bonehypertrophy at a treatment site to promote healing (particularly at thejoint-ward end of the device). Additional information to prevent bonehypertrohy is described in U.S. patent application Ser. No. 15/148,894,filed on May 6, 2016, (now published as U.S. Patent ApplicationPublication No. 2016/0250026 A1), the contents of which are incorporatedherein by reference.

The first section 12 or joint-ward end of the device further comprises acentral aperture 30 within and formed by the central column 24. Thecentral aperture 30 can extend axially completely through the joint wardend 16 as shown particularly in FIG. 9A or can be blind-ended extendingonly partially through within joint-ward end 16 as shown in FIG. 9D, forexample. The central aperture 30 is configured to mate with a driverinstrument as disclosed and described below. The central aperture 30comprises any shape suitable for the intended purpose of the device 10,as will be understood by those with skill in the art with respect tothis disclosure. For example, the central aperture 30 may be a squareshape, a round shape (FIG. 2A and FIG. 6 ), a six-pointed star shape(FIGS. 2B, 2C, 2D, 3, 5 ), a five-pointed star shape (FIG. 7 ) or apentagonal shape (FIG. 8 ), for example. In one embodiment, as shown inFIGS. 2A and 23 , the central aperture 30 comprises threads 32 to assistin mating with a driver instrument.

In another embodiment shown in the cross-sectional, side view of FIG.9D, the hollow central column 1120 of the implantable orthopedic device10 may include a chamfer 1119. The chamfer is essentially a symmetricalsloping surface at an edge or corner 1118. The chamfer 1119 narrows adiameter of the hollow central column 1120 from a diameter of dd′ to adiameter of dd″ to compact the central post 1513 of the subchondral bone1514 when the implantable orthopedic device 10 is placed in the holeover the top of the central post 1513 (as shown in FIG. 15B). Thechamfer 1119 at corner 1118 may include an angle of about 45 degrees,for example. The loading of the central post 1513 is increased and/orresorption of the central post is decreased when the central post of thesubchondral bone is compacted. Additionally, the chamfer 1119 inhibitsformation of bone cysts and/or bone spurs, particularly when the chamferis used in conjunction with the washer 1111 (FIGS. 11A-11E) or cap 1142(FIG. 11G) to recreate separation and form a barrier to sealcompartments of the device 10. The implantable orthopedic device 10 mayinclude a blind-ended central aperture 30 which extends only partiallythrough a joint-ward end 16 of the device 10 such that synovia (i.e.synovial fluid) leakage is mitigated, discouraged or prevented. It'simportant to contain the synovial fluid in the joint cavity since theprincipal role of synovial fluid is to reduce friction between thearticular cartilage of joints during movement. Another advantage of thisembodiment is that it easily permits backfilling during OATS (i.e.osteochondral autograft transfer system) procedures, when healthycartilage from a non weight bearing joint is transferred to a damagedarea of the knee or other anatomical joint.

In one embodiment, peripheral column 22 of the first section 12comprises one or more than one notch 34 as seen in FIG. 2A and FIG. 6 .The notches can be used to mate with a driver in addition to the centralaperture 30 or instead of the central aperture 30, as will be understoodby those with skill in the art with respect to this disclosure.

The joint-ward end 16 of the first section 12 of the device 10 performsa partial load-bearing and/or load-sharing function post implantation,and comprises a shape suitable to substantially match the shape of thearticulation surface that the device 10 recreates on the bone afterimplantation, as will be understood by those with skill in the art withrespect to this disclosure. Therefore, the joint-ward end 16 can haveeither a convex profile as seen on a cross-sectional, lateralperspective view, as shown in FIGS. 9A-9C, a concave profile as seen ona cross-sectional, side view, as shown in FIG. 10 , or even a straightprofile. The joint-ward end may have a convex profile having a radius ofcurvature of between about 10 mm and 50 mm. In one embodiment, a washeris attachable to the joint-ward end of the first section and has aconcave, convex, or flat profile as seen on cross-sectional, lateralperspective view (FIGS. 11-11F).

The lateral wall 20 of the first section 12 can be any shape suitablefor the intended purpose of the device 10, as will be understood bythose with skill in the art with respect to this disclosure. In apreferred embodiment, the lateral wall 20 of the first section 12comprises a generally convex profile as seen on a cross-sectional,lateral perspective view, as shown in FIG. 9A. This convex profileadvantageously provides a smooth transition to and encourages biologicbonding to surrounding cartilage and bone after implantation, as will beunderstood by those with skill in the art with respect to thisdisclosure.

The device 10 further comprises a second section 14. The second section14 of the device 10 comprises a mating end 36, an opposing leading end38, and a lateral wall 40 extending between the mating end 36 and theleading end 38. The second section 14 further comprises an axial length(cc). The axial length (cc) may be between about 5 mm and 30 mm (FIG.1Aa). Preferably, the axial length (cc) is between about 6 mm (FIG. 9B)and about 11 mm (FIG. 9C), for example. In one embodiment, the lateralwall 40 of the second section 14 is generally cylindrical as seen inFIGS. 1A and 9A. In another embodiment, the lateral wall 40 of thesecond section 14 is generally conical, tapering between the mating end36 and the leading end 38 as seen in FIG. 9B. In one embodiment, thelateral wall 40 of the second section 14 tapers between about 0.2degrees and 15 degrees and preferably, the lateral wall 40 of the secondsection 14 tapers about 9 degrees (FIG. 9B).

The mating end 36 of the second section 14 of the device 10 isconfigured to mate with the mating end 18 of the first section 12 of thedevice 10. The mating end 18 of the first section 12 and the mating end36 of the second section 14 can comprise any mating mechanism suitablefor the intended purpose of the device 10 can be used, as will beunderstood by those with skill in the art with respect to thisdisclosure. In one embodiment, the mating end 18 of the first section 12and the mating end 36 of the second section 14 mate by a suitablebiocompatible adhesive, as will be understood by those with skill in theart with respect to this disclosure. In a preferred embodiment, themating mechanism is reversible, allowing an interchange of an alternatefirst section 12 to a specific second section 14 so that the device 10can be reconfigured as needed for contouring to a particular jointsurface, thereby decreasing the number of second sections 14 that needto be stored on site, as will be understood by those with skill in theart with respect to this disclosure. In one embodiment, the mating end18 of the first section 12 and the mating end 36 of the second section14 mate by a reversible twist locking mechanism, as will be understoodby those with skill in the art with respect to this disclosure. Inanother embodiment, the first section 12 and the second section 14 aremade as a unified whole as shown in FIGS. 9B-9C and are not separable.

The first section 12 and the second section 14 can comprise any materialsuitable for the intended purpose of the device 10, as will beunderstood by those with skill in the art with respect to thisdisclosure. The first section 12 may comprise a material selected fromthe group consisting of a biocompatible plastic, a biocomposite polymer,a metal and a metal alloy or a material selected from the groupconsisting of carbon fiber, cobalt chrome, nitinol (e.g. nickeltitanium), polycaprolactone (PCL), polyether-ether-ketone (PEEK),tantalum and titanium. In one embodiment, the second section 14comprises a material selected from the group consisting of abiocompatible plastic, a biocomposite polymer, a metal and a metalalloy. The second section 14 comprises a material selected from thegroup consisting of carbon fiber, cobalt chrome, nitinol,polycaprolactone (PCL), polyether-ether-ketone (PEEK), tantalum andtitanium. The first section 12 may comprise a first material and thesecond section 14 may comprise a second material, where the firstmaterial and the second material are the same or are differentmaterials.

The device 10 can be made by any suitable method, as will be understoodby those with skill in the art with respect to this disclosure. In oneembodiment, the first section 12 and the second section 14 are machinedfrom modular parts such as by additive manufacturing (AM), direct metallaser sintering (DMLS), selective laser sintering (SLS), selective lasermelting (SLM), metal injection molding (MIM), laser engineered netshaping (LENS), 3D printing, 3D bioprinting (i.e. printing usingbiologic tissues) computer-added design/computer aided manufacturing(CAD/CAM), as will be understood by those with skill in the art withrespect to this disclosure. Alternatively, device 10 may be made as amonobloc device. The device 10 may be produced in a customized fashionto correspond to a specific joint anatomy, including bipolar and/orgender-specific differences, for example.

The leading end 38 of the second section 14 of the device 10 isconfigured to place the device 10 into a prepared space made accordingto a method according to the present invention. In one embodiment, theleading end 38 comprises a scalloped edge 42. In another embodiment, theleading end 38 comprises bevels 44. The leading end 38 may comprise botha scalloped edge 42 and bevels 44 as shown particularly in FIGS. 1Aa,1D, 2A, 2D and 3 , for example. In one embodiment, the leading end 38comprises a beveled edge 44 as shown in FIGS. 1B, 1C, and 9D, forexample. Alternatively, the leading edge 38 may not comprise bevelededges (FIG. 1Ab). In yet another embodiment, the scalloped edge 42 maybe a the shape of the letter “V” rotated 180 degrees (FIGS. 1Ab and 2A)or the shape of the letter “U” rotated 180 degrees (FIG. 2D), forexample. In some embodiments, the scalloped edge may be relativelypronounced (i.e. resembling table legs) to reduce material cost andlower the overall profile of the implant (FIG. 1Ab). The implant mayinclude threads 46 along the lateral wall 40 or lack threads as shown inFIGS. 1Aa and 1Ab, respectively.

The lateral wall 40 of the second section 14 of the device 10 extendsbetween the mating end 36 and the leading end 38. The lateral wall 40 ofthe second section 14 comprises threads 46 for anchoring the device 10within the bone. In one embodiment, the lateral wall 40 of the secondsection 14 further comprises a plurality of fenestrations 48 between thethreads 46 (FIGS. 1Aa, 1B, 1C and 1D). In a preferred embodiment, thedevice 10 further comprises a plurality of fenestrations 50 formed by aconfluence of the mating end 18 of the first section 12 and the matingend 36 of the second section 14 (FIG. 1Aa and FIG. 3 ). Eachfenestration 48, 50 can comprise any size or shape suitable for theintended purpose of the device 10, including, but not limited to,providing support for different tissue types to promote healing andrepair at the treatment site. In a preferred embodiment, thefenestrations may be oval, round, or other shapes. In one embodiment,the lateral wall 40 of the second section 14 is textured to promote bonyingrowth after implantation, as will be understood by those with skillin the art with respect to this disclosure. The fenestrations betweenthe protrusions on the second section of the lateral wall are betweenabout 300 microns and 1200 microns in size to promote bone growth whilethe plurality of fenestrations on the joint-ward end of the firstsection are between about 400 microns to 800 microns in size to promotecartilage growth. The fenestrations may take for form of pores, witheach pore sized about 800 microns in diameter to promote bone growth.Pores sized about 500 microns in diameter may be best suited to promotecartilage growth. The external surface of the device is at leastpartially textured to increase the surface area of the device. Thetexture may include a dimpled pattern or even a “pattern 701 within apattern 702” configuration shown in FIG. 7 , for example. Anothervariation of this “pattern 801 within a pattern 802” configuration isdepicted in FIG. 8 . Of course, a multitude of other such patterns arecontemplated and the invention is not limited to the explicit examplesprovided herewith.

As shown FIGS. 1D, 4D, and particularly in FIG. 2D, a plurality offenestrations 48 a, 48 b are located between the threads 46 a includingat least some fenestrations 48 b positioned in vertical alignment withnotches 46 b. The notches are located along (i.e. track) the spiralthread path. The notches 46 b are intermittently spaced along thethreads path and intermittently interrupt the thread path. In thisembodiment, one end of a suture or similar materials may be threadedthrough the fenestrations(s) 48 b on one side of the device 10 andsecured in place with a knot, clip or other fastener at each fixationpoint. The other end of the suture may be wrapped over the joint-wardend 16 and threaded (i.e. inserted) through fenestration(s) 46 b onanother side of the device 10 to substantially hold a biomaterial inplace on the top of the joint-ward end 16 of the device. The discussionbelow with respect to FIGS. 11Ha through 11Hi elaborates on thisparticular embodiment.

Referring to FIG. 10 , the joint-ward end 16 may be concave. A washer1111, 1121, 1131 may be attached to the joint-ward end of the device viathreads 1141, spikes 1151 or snap-fit 1161 as shown in FIGS. 11B-11D,respectively. The threads may include reverse cutting threads, notchedthreads, tapered threads, buttress threads, metric threads, trapezoidalthreads, acme threads, pipe straight threads, unified threads, customthreads and multi-threads. The washer may have a convex 1611, concave1612, or flat 1613 geometric surface. The washer 1111 may also be slidin direction 1181 such that tracks 1171 meet and engage thecorresponding groove 1191 of the device 10 to secure the washer 1111together as depicted in FIG. 11E, for example. FIG. 11F is a top view ofthe joint-ward end of device 10 showing chambers 1201 that may hold acarrier substance 1211 such as a polymer, or biomaterial, or medicine,or a hybrid combination thereof. The biomaterial may include cartilage,osteocartilage, a chemotactic substance or a cellular differentiationsubstance (including stem cells), for example. The medicine may includean antimicrobial, antibiotic, antiviral or chemotherapeutic agent, forexample. The therapeutic biomaterial may possess chemotactic, cellularhoming, biological crosstalk and/or time-release capabilities andpromote tissue growth, encourage bleeding and inhibit infection tofacilitate repair of the anatomical joint.

FIG. 11G depicts another embodiment wherein a cap 1142 may be secured tothe joint-ward end 16 of the device 10 via snap-fit arrangement 1145. Amale portion 1143 of the cap 1142 engages a female portion 1144 of thejoint-ward end 16 of the device 10. The cap 1142 may hold a carriersubstance 1146 containing a polymer, or biomaterial, or a hybridcombination thereof.

As shown in the sequence of FIGS. 11Ha-11Hc, a carrier substance 1147may be positioned 1149 substantially over (e.g. on top of) thejoint-ward end 16 of the device 10 and fastened into place using one ormore strands 1148 a, 1148 b, 1148 c, 1148 d, 1148 e. The strands mayinclude suture material including absorbable sutures (e.g. polyglactin,poliglecaprone, polydioxanone) and non-absorbable sutures (e.g. nylon,dacron, silk, polypropylene), as well as elastic bands, laces, strings,tethers, or similar material. The strands may be substantially round,oval or flat in cross sectional area and may be bonded to, orimpregnated with, therapeutic agents. The strands may additionallyinclude an aglet 1152 a at one or both ends of the strand 1152 b tofacilitate threading the strand 1148 c through fenestration 48 b Afterthreading the strand end 1152 a through fenestration 48 b, the end maybe attached by a knot 1150 or other securing contrivance. The oppositeend 1152 b (i.e. non-secured end) of the strand 1148 c is looped acrossthe carrier substance 1147 and the end 1152 b is threaded through afenestration opposite (or adjacent) the fenestration 48 b and anchoredin place using a knot or other fastener to secure the strandsubstantially taut with a sufficient tensile strength across thejoint-ward end 16 to hold the carrier substance 1147 in place. Thecarrier substance and/or one or more strands may be secured pre- orpost-implantation of the device 10 into the bone. If the one or morestrands are attached in a configured pattern before the carriersubstance 1147 is positioned, strand(s) with some elastic properties maybe preferred to allow the strand(s) to be lifted (i.e. stretched upwardaway from the joint-ward end 16 of the device) to create a sufficientspace to allow the carrier substance to be tucked into position underthe strand(s), for example. Sliding self-locking sutures may also beemployed.

Should the strands be secured post-implantation, at least one level offenestrations need to be accessible to secure the strands. When theimplant is secured substantially flush with the joint articulation,exposing at least one row of fenestrations and notched threads can beaccomplished by clearing tissue around the circumference of theimplanted device using a reamer or other instrument. In one embodimentof the invention, indications 156 may be included on the top surface ofthe joint-ward end 16 of the device to assist in visually locating thenotches and fenestrations when the device is implanted substantiallyflush with the hone surface. One example of the indication 156 is shownin FIG. 4D where the indication is an engraved “N”. The strands may alsobe secured while the device is only partially implanted and the devicecan subsequently be implanted substantially flush after the strands havebeen attached. In this manner, removal of tissue around a circumferenceof the device to access the fenestrations is minimized or avoided. Thenotches 46 b between the threads 46 a serve as guides for the strands,including sutures and keep them in place to prevent their migration(i.e. rolling, sliding) to the right or left side of the fenestration towhich they are attached. The notches 46 b in this particular embodimentalso prevent the sutures from running over and across the sharp threads.In this manner the notches reduce the risk of the strand becomingweakened (e.g. frayed or severed), for example.

As shown in FIG. 11Hm, a carrier substance 1147 may be preloaded on thedevice 10. The word “preloaded” refers to an embodiment where thecarrier substance 1147 is attached to the device 10 before the device ispartially or fully implanted at a treatment site (i.e. bone defect). Oneadvantage of preloading the carrier substance is that it saves timeduring the procedure. In this emboidment, the carrier substance 1147 isattached to an edge of the joint-ward end 16 of the device. Theattachment may be made with one or more strands or other attachmentmeans. In this manner, the carrier substance 1147 can be visualized as a“lid flap”, for example. The strand(s) 1148 a are loosely attached toanother side (or sides) of the device with some slack so that thecarrier substance 1147 is positionable off center relative to thecentral aperture 30. This leaves the central aperture 30 accessible tothe driver instrument. After the device has been implanted at thetreatment site and the driver instrument has been removed, the carriersubstance 1147 is cinched down substantially over (e.g. on top of) thejoint-ward end 16 of the device 10 by pulling on the loosely attachedstrand(s) to remove the slack. The strand(s) may then be secured inplace with a knot, sliding self locking sutures, or other means ofattachment 1150. The strands may include suture material includingabsorbable sutures (e.g. polyglactin, poliglecaprone, polydioxanone) andnon-absorbable sutures (e.g. nylon, dacron, silk, polypropylene), aswell as elastic bands, laces, strings, tethers, or similar material. Thestrands may be substantially round, oval or flat in cross sectional areaand may be bonded to, or impregnated with, therapeutic agents.

The configuration of strands shown in FIGS. 11Ha-11Hc include a total of5 separate strands positioned in an “asterisk” pattern (FIG. 11Hc).However, a multitude of other patterns are contemplated base on variousfactors and considerations. These considerations may include, but arenot limited to, the thickness of the carrier substance, the compositionof the strand material, the area of the bone defect in proximity to thejoint-ward end of the device, and the preference of the surgeon, forexample. Many of these considerations are specific to the individualrepair and associated anatomy. A few examples of suture patterns using asix-point suture fixation attachment, including a “hexagon” (FIG. 11Hd),“letter H” (FIG. 11He), “single strand” (FIG. 11HO, “geometrictrampoline” (FIG. 11Hg), “random web” (FIG. 11Hh), and “letter X” (FIG.11Hi) are shown in top views of FIG. 4D after the carrier material 1147has been positioned. In this embodiment, the carrier material isattached to the device without disturbing the surrounding cartilage.

More than a single suture may be weaved, stitched or otherwisepositioned across the same area in the same direction as shown bysutures 1148 b, 1148 b′ in FIG. 11Hh, for example. This pattern offersadditional strength on the left side to hold the carrier material 1147in place in this particular example. It is also contemplated thatseveral embodiments may be combined to secure the carrier substance inplace. For example, the snap-fit cap shown in FIG. 11G may additionallybe sutured according to embodiments shown in FIGS. 11Ha through 11Hi.

In addition to suturing the carrier substance to the implant, thecarrier substance may be bonded to the implant using adhesives or coatedon the implant. One such coating may include hyrdoxypatite (HA), forexample. Regardless of how the carrier substance is attached to theimplant, the carrier substance may be secured to the implant eitherbefore or after implantation of the device 10 into the bone.

It will be appreciated that there are numerous stitches and suturethreading patterns that may be employed to secure a carrier substancecontaining a polymer, or biomaterial, or medicine or a hybridcombination thereof to an implantable orthopedic device according to themethods and devices described herein. Additionally, the suture fixationis not limited to six-point fixation attachment and may be attachedusing sutures attached at three fixation points rather than six, forexample, as shown in FIGS. 11Hj through 11Hl. These variations as wellas variations in the design of the above-described devices andinstruments are within the scope of the present disclosure.

Turning now to FIG. 12A, flares 1299 may be used to firmly attach thedevice 10 to the bone. The flares 1299 may be used alone or incombination with threads 46.

Furthermore, the flares may be located on the outside of the device 1299or on the inside of the device 1298 (FIG. 12B) or a combination ofthereof. The flares 1298, 1299 can also be used in combination withthreads 46 to anchor the device 10 securely to the bone.

One or more vascular channels may be created in the subchondral bone atthe treatment site to facilitate beneficial bleeding. These vascularchannels 1511, 1512 are shown in FIG. 15B, for example. The vascularchannels are created by drilling, reaming, tapping, boring, or pokinginto the bone. It has been found that some minor bleeding actuallypromotes healing as the blood wicks upward toward the treatment site. Inthis regard, FIGS. 13A and 13B are top views of groove configurations onthe inside (FIG. 13A) or outside (FIG. 13B) of device 10 to allow bloodwicking. As seen in FIG. 13C, the grooves may be arranged in a verticalconfiguration 1313 on the device with each groove substantially parallelto a neighboring groove. Spiral configurations 1314 (FIG. 13D) and manyother groove configurations are contemplated.

According to an embodiment of the invention, an anatomical jointcondition is repaired by removing an inner circular portion of thesubchondral bone to create a space 116 while preserving a central post1413 of subchondral bone a substantially undisturbed native state usinga cannulated drill or other similar orthopedic instrument. FIG. 14A is atop view of the central post 1413 and the surrounding bone 1414. FIG.14B is basically a side view of FIG. 14A showing the central post 1413and space 116. After the space 116 is created, vascular channels may bemade in a relatively deeper vertical direction 1412 and/or made in anangled direction 1411 to provoke bleeding. See also channels 1511 and1512 in FIG. 15B.

FIG. 15A (presented in subparts 15Aa and 15Ab on separate sheets) is aflow chart outlining steps to repair an anatomical joint condition usingthe present invention. The surgeon begins the procedure 1515 bysurgically accessing the treatment site 1516. Optionally, an inflatableenvelope and/or a cannula may be positioned to retract the tissue so asto have better access to the treatment site 1517. A sizing instrument iscentrally positioned over the defect at the treatment site on thesubchondral bone 1518. A diameter of the defect is measured withconcentric rings on the sizing instrument by comparing the defectdiameter with the closest corresponding known diameter on the sizinginstrument 1519. A guidewire is inserted through the lumen of thecylindrical member while the distal end of the sizing instrument iscentrally positioned over the defect 1520. The subchondral bone iscontacted with a distal end of the guidewire and the center of thedefect is marked by reversibly attaching the guidewire to thesubchondral bone 1521. Next, the sizing instrument is removed over theguidewire 1522. A countersink instrument is selected that has a diametersubstantially matching the measured diameter of the defect 1523. Thecountersink instrument is positioned over the guidewire 1524. Thethickness of the countersink mimics the thickness of the joint-ward endof the implant. By simultaneously rotating and lowering the countersinkto engage a soft tissue and the subchondral bone, the subchondral boneis penetrated with the countersink to form a hole 1525 having a firstdepth. The first depth is checked 1526. If the hole is too shallow toallow placement of the device 1527 at a desired depth, the step 1525 isrepeated. If the desired depth is acceptable (i.e. the device is flushwith the bone surface, countersunk slightly below the bone surface, orslightly protruding above the bone surface as shown in FIGS. 16Ta-16Tc,respectively), the first depth may be considered acceptable 1528 and thecountersink may be removed over the guidewire 1529. A cannulated drillis positioned over the guidewire 1530. An inner circular portion of thesubchondral bone is removed 1531 while preserving a central post ofsubchondral bone in an substantially undisturbed native state bysimultaneously rotating and lowering the cannulated drill into a centerof the countersink hole. The inner circular portion has a second depthwhich is checked 1532. If the second depth is too shallow, step 1531 maybe repeated. If the second depth is found to be slightly deeper that thedevice length 1534, then the cannulated drill can be removed over theguidewire 1535. At this stage, one or more vascular channels may becreated in the subchondral bone 1536. Next, a protective sleeve isoptionally placed over an implantable orthopedic device 1537 and thedevice is implanted in the patient. The device is positioned in the holeover a top of the central post and the sleeve is removed 1538. Thecentral bone post is accepted by a hollow central column of the devicewhen positioned/implanted. The orthopedic device is secured in the holeusing a driver instrument 1539 and the driver instrument is removed. Theguidewire is detached from the subchondral bone 1540 and the guidewireis removed. The treatment site is closed 1541 at the conclusion 1542 ofthe repair procedure.

FIG. 15B is a cross section of one embodiment of the present inventionfor repairing an anatomical joint. For purposes of the followingnarrative, the bone 1514 will be referred to as a subchondral bone at aknee joint; however, the following description could be used for anybone requiring anatomical joint repair. The subchondral bone 1514surface 104 has been prepared at the defect site by penetrating the bonewith a countersink instrument to a first depth gg and removing an innercircular portion of the bone using a cannulated drill to a second depthhh while keeping a central post of subchondral bone 1513 fundamentallyintact and substantially undisturbed. By removing an inner circularportion of bone, a circular space 116 is created. Preserving the centralpost 1513 provides structural integrity to the treatment site andfacilitates repair since less bone is removed. The second depth hhencourages blood flow 124 around the walls of the central post 1513.Vascular channels 1511, 1512 may be created at various angles and depthsto tap into the vasculature (i.e. capillary bed) 1510 to promotebleeding 124. Bleeding may include laminar blood flow, turbulent bloodflow, capillary blood flow, and percolatory blood flow, for example.

An implantable orthopedic device 10 is placed over the top of the post1513 as shown in direction 1515. The width dd of the device 10 may beslightly wider that the width ff of the post 1513. The length aa of thedevice 10 may be slightly less than or equal to the second depth hh toallow sufficient placement of the device 10. The central post 1513accepts the hollow central column of device 10. When device 10 is fullyimplanted, the joint-ward end 1516 of device 10 is substantially flushwith the surface 104 of the subchondral bone 1514 (e.g. the first depthgg allows placement of the device 10 at an substantially flushorientation with the bone surface 104) via countersink hole. In somesituations, as shown in FIG. 16Tb, the joint-ward end 1516 of the device10 may be implanted slightly below a surface 104 of the subchondral bone1514 to account for a thickness of a carrier substance that mayoptionally be attached to the joint-ward end of the device either pre-or post-implantation. The inner circular portion of removed bone (i.e.space 116) has a diameter less than or equal to the diameter of thecountersink hole.

According to another embodiment of the present invention, there isprovided a method for repairing an anatomical joint condition or diseasein a patient. Referring now to FIGS. 16A through 16L, there are shownschematic depictions of some steps of a method for repairing anatomicaljoints and ameliorating joint conditions and diseases, as well aspreparing a defect at a treatment site on a subchondral bone to repairan anatomical joint according to the present invention. In this example,the figures illustrate one embodiment of the method being used on afemorotibial joint 100 to ameliorate an arthritic condition which hascaused a defect 102 on an articulation surface 104 of a bone or joint,shown here as on the medial condyle 106 of the femur 108.

A patient is first identified with a joint condition or disease that issuitable for treatment by the present method, where the joint comprisesa bone with a surface comprising a defect caused by the joint conditionor disease. Diagnosing the patient may include performing one or morethan one action, including performing a physical examination, performinga non-invasive imaging examination (such as magnetic resonance imaging,computerized tomography and ultrasound), performing arthroscopy orsimply consulting patient records to determine if the patient has ajoint condition or disease suitable for treatment by the present method.As will be understood by those with skill in the art with respect tothis disclosure, the joint can be any joint with a hyaline cartilagebearing surface, joint capsule, and synovial fluid. The joint may be adiarthrodial joint (i.e., synovial joint). In one embodiment, the jointis selected from the group consisting of an acetabulofemoral joint, anacromioclavicular joint, a femoropatellar joint, a femorotibial joint, aglenohumeral joint, a humeroradial joint, a humeroulnar joint, aninterphalangeal joint, a metacarpal joint, a radioulnar joint and atalocrural joint. In one embodiment, the patient may be a human or anon-human animal. In a preferred embodiment, the joint condition anddisease is selected from the group consisting of arthroses,chondromalacia patella, isolated chondral defect, juvenile idiopathicarthritis, ligamentous deficiency arthroses, osteoarthritis(degenerative arthritis or degenerative joint disease), osteonecrosis,osteochondritis dissecans, patellar instability, post-ligamentous injuryarthritis, post-meniscectomy arthritis, post-meniscectomy arthroses,post-traumatic arthritis, septic arthritis, rheumatoid arthritis andgenetic defects. In one embodiment, identifying the patient comprisesdiagnosing the patient with a joint condition and disease.

The method further comprises accessing the joint treatment site 100 viaarthroscopy or by an open surgical procedure, such as for example amini-open procedure.

As shown in FIGS. 16B and 16C, the surface 104 of the bone includes anabnormality (i.e. defect) 110 (such as for example area cartilagesoftening, thinning, damage, or absence), and a burr and/or a suctionshaver 112 may be used to remove some or all of the abnormalities 110thereby creating a smoother articulation surface 104 as shown in FIG.16C.

As shown in FIG. 16D, the distal end of a sizing instrument 1909 isplaced over the defect 102 to measure the defect using the concentricrings 1902 a, 1902 b on the sizing instrument by comparing the defect102 diameter with the closest corresponding known ring diameter 1902 a,1902 b on the sizing instrument 1909.

The method further comprises inserting a guidewire 114 through the lumen1903 of the sizing instrument 1909 when the sizing instrument ispositioned over the center of the defect 102. The distal end of theguidewire 114 contacts the bone and reversibly attaches to the bone tomark the center of the defect 102. The sizing instrument 1909 is removedover the guidewire 114 while the guidewire 114 remains attached to thebone as shown in FIG. 16E.

A countersink instrument 2601 is positioned over the guidewire 114 andmoved onto contact the defect 102 (FIG. 16F). As shown in FIG. 16G, thecountersink instrument 2601 is rotated 2602 to remove soft tissue andsome bone to a given depth. The countersink is removed over theguidewire when a sufficient depth has been determined.

Next, the method further comprises creating a space 116 in the defect102 of the bone for a device. In one embodiment, the space 116 iscreated using a cannulated drill 118 placed over the guidewire 114 tocore and plane the surface of the defect 102 as shown in FIG. 16H, andFIG. 161 . The cannulated drill 118 is then removed leaving theguidewire 114 in place.

In one embodiment, the method further comprises creating one or morevascular channels in the bone deep to the space 116 using a drill bitguide 120 positioned over the guidewire 114 (FIG. 16J) and a drill bit122 passed within the drill bit guide 120 (FIG. 16K). Confirmation ofcreation of the one or more vascular channels is made by the presence ofblood 124 leaking into the space 116 from the one or more vascularchannels as shown in FIG. 16L, for example. The drill bit guide 120 anddrill bit 122 are then removed leaving the guidewire 114 in place.

Next, the method further comprises providing a first device 126 forrepairing joint conditions suitable for ameliorating the joint conditionor disease of the patient as can be seen in FIG. 16M which includes asterilizable kit containing packaging 1601, instructions 1602 and otherinstruments and materials for repairing joint conditions as describedherewith. In one embodiment, the first device 126 is a device accordingto the present invention. The first device 126 provided has a sizesuitable for incorporation into the space 116 made in the defect 102,and the joint-ward end of the first device 126 comprises a shapesuitable to substantially match the shape of the articulation surface104 that the first device 126 recreates on the bone after implantation,as will be understood by those with skill in the art with respect tothis disclosure. Referring now to FIG. 16N, the first device 126 isattached to a driver 128, such as for example by mating the distal endof the driver 128 with the central aperture of the first device 126. Inone embodiment as shown in FIGS. 22A-22B, the method further comprisesoptionally covering the device 126 with a sleeve 155 before positioningthe device 126 in the patient. The sleeve 155 protects the surroundingtissues as the device 126 is moved through tissues and ultimatelypositioned into the space 116 made in the defect 102. The sleeve 155 isremoved just prior to placement of the device 126 at the site of thedefect 102 (e.g. before the orthopedic implant is positioned in the holeover a top of the central post). The sleeve 155 may be made of atransparent or semi-transparent material to facilitate visualorientation of the device and sleeve removal over the defect 102.

In one embodiment, the method further comprises injecting a biomaterial130 such as a biologic material (i.e. stem cells or platelet-richplasma, or both stem cells and platelet-rich plasma) into the firstdevice 126 using an injector 132 as shown in FIG. 160 . In oneembodiment, the method further comprises placing an insert according tothe present invention in the first device 126 instead of injecting abiocompatible bone cement in the first device 126. In one embodiment,the insert is a biological material according to the present invention.

The method further comprises screwing the first device 126 into thespace 116 using the driver 128, as shown in FIG. 16P through, FIG. 16S.FIGS. 16Ta-16Tc are partial, lateral cross-sections of the medialcondyle 106 at the site of the defect 102 showing placement of the firstdevice 126. As can be seen in FIG. 16Ta, the joint-ward end of the firstdevice 126 forms a shape that substantially recreates the shape of anormal articulation surface on the bone after implantation. In thisexample the device is implanted substantially flush with a surface ofthe bone. This facilitates load-sharing. FIG. 16Tb alternatively showsthe device 126 slightly countersunk below the surface of the bone with acarrier substance 1147 attached to the joint-ward end to facilitatetissue ingrowth, osteointegration, and healing. FIG. 16Tc alternativelyshows the device 126 protruding slightly above the surface of the bone.This facilitates weight-bearing.

In one embodiment, as can be seen in FIG. 16Ua, the method furthercomprises placing one or more than one additional device 134, 136 in thedefect 102. In one embodiment, the one or more than one additionaldevice is one additional device. In another embodiment, one or more thanone additional device is two additional devices. As will be understoodby those with skill in the art with respect to this disclosure, the oneor more than one additional device 134, 136 can be the same as the firstdevice in terms of size and shape or can be different than the firstdevice in terms of size and shape.

In another embodiment, a carrier substance containing a polymer, orbiomaterial, or a hybrid combination thereof may be secured among and/orbetween more than one implantable orthopedic device. FIG. 16Ub is anenlarged version of FIG. 16Ua showing the devices 126, 134, 136 anddefect 102. Devices 126, 134, 136 may be the same or different sizeversions of the device 10 embodied in FIGS. 11Ha-11Hc, for example. Thecarrier substance 1147 may be secured on the joint-ward end of eachdevice before or after implantation as previously described. FIG. 16Ubshows the carrier substance 1147 individually secured among each ofthree different sized devices. FIG. 16Uc shows the carrier substance1147 spanning an area between devices 126 and 136 with sutures 1148 a,1148 b attached (e.g. tethered). In this example, the suture strands areshared with devices 126, 136 to secure the carrier substance 1147 inplace over the defect 102 located generally between the devices 126,136. An second carrier substance is separately secured to device 134. Inanother configured pattern as shown in FIG. 16Ud, the carrier substance1147 is secured with sutures among and between devices 126, 134, 136 tocover the majority of the defect 102. In yet another embodiment, FIG.16Ue shows the carrier substance 1147 secured between devices 126, 134,136 with strands 1148 a shared among the devices.

There are many combinations of suture threading patterns, anchor typesand sizes, anchor placement locations, and deployment sequences that maybe used to attach a carrier substance among and/or between more than oneimplantable device according to the methods and devices describedherein. The carrier substance may include a mesh, substrate, washer, orpouch configuration and may be attached via sutures, staples, coatings,adhesives, or similar attachment to a threaded (FIG. 1Aa), press-fit(FIG. 12A) or smooth (FIG. 1Ab) implantable orthopedic device eitherbefore or after the device has been implanted into the bone. Thesevariations as well as variations in the design of the above-describeddevices and instruments are within the scope of the present disclosure.

Though the method of the present invention has been disclosed withrespect to a defect 102 in a femorotibial joint 100, correspondingmethods can be used with other joints. FIG. 16V is a partial, lateralcross-section of a glenohumeral joint 138 at the site of a defectshowing placement of a device 126 for repairing joint conditionsaccording to the present invention.

FIGS. 17A through 17C, show a cannula 1701 a for arthroscopicallyretracting a target tissue at an anatomical joint. The cannula 1701 acomprises a delivery tube 1702 with a distal end 1704, a proximal end1705, and an elongate member disposed between the distal and proximalends. A guided slot 1703 runs at least partially along a length of theelongate member and a rod-like retractor 1706B configured for movableinsertion 1707 in the delivery tube along slot 1703. The retractor has adistal end 1709, a proximal end 1708, and an elongate section disposedbetween the distal and proximal ends. As shown in FIGS. 17B and 17C, thedistal end 1709 of the retractor may be bent at an angle 1710 betweenabout 1 degree and 179 degrees relative to the elongate section. Whenthe cannula is used to retract target tissue at an anatomical joint, thedistal end of the retractor is configured to movably track along theslot 1703 and engage and retract the target tissue in an substantiallyproximal direction relative to an axis of the delivery tube when a force1712 is applied to the proximal end of the retractor. The distal end1709 may be rotated about an axis 1713 to assist in engaging a targettissue. The delivery tube 1702 of the cannula 1701 a may be bendable toconform to a number of shapes including a curved shape as shown in FIG.17D, a sigmoid shape as shown in FIG. 17E, or any other shapes thatassist in engaging and retracting a target tissue within a sometimestortuous path within an anatomical joint space. The bendableconfigurations may be reversibly customizable via application of one ormore directional forces along the delivery tube 1702.

A cannula 1701 b, 1701 c with a “half pipe” design feature is shown inFIGS. 17Fa, 17Fb and 17G. The distal tip 1716 of the cannula is shapedlike the letter “C” when viewed in cross section (FIG. 17Fa). Thecannula 1701 b may be a transparent material (e.g. clear plastic) asshown in FIG. 17Fb or the cannula 1701 c may be an opaque material suchas metal as depicted in FIG. 17G, for example. The shape of the cannulafacilitates visualization of the implant as it is delivered to thedefect. Openings 1714, 1715 may also serve this purpose.

The half pipe feature may include only a few millimeters from the tip1717 or run substantially along the entire length 1718 of the cannula1701 b. The cannula 1701 d may also include teeth 1716 a, as shown inFIG. 17H, to hold the cannula in place as the implant is delivered tothe target tissue site. The cannula 1701 a, 1701 b, 1701 c may be usedwith or without a guidewire.

FIG. 18A is a lateral perspective view of an embodiment of the presentinvention. In this embodiment, the cannula 1802 includes an inflatableretractor preferably located near the distal end 1804 that may inflatearound some 1806, most 1805 or all 1803 of the cannula 1802 as shown incross section (FIGS. 18D, 18C and 18B), respectively. When the retractoris inflated, the target tissue is moved away from the defect 102 toallow enhanced access and visualization of the defect during reparationof the anatomical joint.

FIG. 19A is a side view perspective of a human knee joint showing anembodiment of the present invention. As shown, an inflatable envelope1901 has been arthroscopically inserted into a targeted space. In thisexample, the targeted space includes the suprapatellar pouch 1902between the femur 108 and the quadriceps muscle 1903 near the human kneejoint. Of course, the envelope 1901 may be inserted in any number oflocations, including between the femur 108 and patella 1904, forexample. When the envelope is inflated, it displaces tissue by inflationpressure to allow better access and visualization of the defect.

The envelope may be inflated by a gas or liquid (i.e. saline solution),for example.

FIG. 19B shows the envelope in a deflated state prior to insertion. FIG.19C shows the envelop inflated by introducing a gas or liquid throughnozzle 1905. The envelope can be configured to inflate in manydirections 1906, 1907, 1908. It is generally preferred to have theenvelope to inflate primarily in direction 1906 to act as a type of“joint jack” (e.g. similar to a car jack elevating an automobile to aidin replacing a flat tire).

FIGS. 20A-20B and 20D are perspectives views of countersink instrument2601 of another embodiment of a device for repairing anatomical jointconditions according to the present invention. Lumen 2001 provides forthe insertion of the guidewire 114 in use. The countersink instrument2610 may include 2 or more blades equally spaced apart from one another.FIGS. 20A-20D show 4 total blades 2602, 2603, 2604, 2605. FIG. 20C showsa bottom perspective view the countersink instrument shown in FIGS.39A-39B and 39D. FIG. 20E is a perspective view of a countersink hole2606 prepared in bone 104 using the countersink instrument 2601 in FIGS.20A-20D. FIG. 20F is a cross section of a countersink hole 2606 preparedin bone 104 using the instrument 2601 shown in FIGS. 20A-20D. Thecountersink instrument 2601 is used to basically clear soft tissue anddrill a countersink hole in the bone before using the cannulated drill.

Turning now to FIG. 21A, a cannulated drill 118 a includes 2 prongs(i.e. blades) 2101, 2102 spaced equally apart from each other. Thecannulated drill 118 c may have 4 prongs 2106, 2107, 2108, 2109 as shownin FIG. 21C. However, the 3 pronged 2103, 2104, 2105 cannulated drill118 b shown in FIG. 21B is preferred as it is more likely to drill atrue hole without clogging bone into area 2110 between prongs, forexample. The cannulated drill 118 a, 118 b, 118 c removes bone 104 whileleaving a center core 1513 of bone intact below the countersink hole2606. This is shown in perspective view (FIG. 21D) and a cross sectionalview (FIG. 21E) using the instruments in FIGS. 21A-21C. The countersinkinstrument 2601 and/or cannulated drill 118 a, 118 b, 118 c may be madeout of stainless steel, titanium or other materials commonly known inthis technical field, for example.

FIG. 23A is a perspective view of a driver instrument 157 thatreversibly engages an implantable orthopedic device 10. The device isconfigured to implant in a bone 102. The driver instrument 157 comprisesa distal end 158 having a male configuration including acentrally-located threaded protuberance 159 and relatively shorterelongate knobs 160 a, 160 b, 160 c. The knobs form a diameter around theprotuberance 159. When the driver instrument 157 is aligned in proximity161 with the implantable device 10, lowered 166 into position, androtated 162 in one direction, the threaded protuberance 159 engages amirror reverse female configuration 163 located on a joint-ward end 164of the implantable device. Continued rotation 162 causes the knobs 160a, 160 b, 160 c to engage the corresponding female configuration 165 a,165 b, 165 c on the implantable device to provide sufficient leverage toimplant the implantable orthopedic device 10 in the bone 102 as shown inFIG. 23B. Rotating the driver instrument in the opposite direction 168allows the knobs 160 a, 160 b, and 160 c and threaded protuberance 159to disengage with the now implanted device 10 and the driver instrument157 is removed from the area 169 as shown in FIG. 23C.

Turning now to FIG. 24A, an extraction tool 171 is shown in a crosssectional view. The extraction tool may be used for removing anorthopedic device 10 implanted in a bone 102. The extraction tool 171comprises a distal end 172, a proximal end 173 and an elongate member174 disposed between the distal end and the proximal end. The elongatemember 174 includes a conduit 175 running at least along a length of thedistal end 172. The conduit 175 includes two or more nubs 176 a, 176 b.Each nub is between about 0.5 and 1.5 mm in length. Preferably, each nubis about 0.9 mm in length. The nubs 176 a, 176 b project from an insidesurface 177 of the conduit 175. As shown in FIGS. 24B and 25A-25B thenubs are configured to engage and slide past 178 corresponding notches46 b spaced vertically along thread 46 a paths of the implantableorthopedic device 10 such that, when the extraction tool 171 is placedover an exposed surface 180 (e.g. a surface not implanted in bone) ofthe implantable orthopedic device 10, and the two or more nubs 176 a,176 b engage 181 and slide 178 past the corresponding notches, theextraction tool 171 is rotated in either direction 179 to seat thenotches between thread paths. Once seated, the extraction tool allowsefficient leverage when twisting and/or pulling to remove the devicefrom the bone in use. Once the device is removed from the bone, theextraction tool can be separated from the orthopedic device by rotatingthe extraction tool relative to the orthopedic device to unseat the nubsfrom between the thread paths and then aligning the nubs with thenotches. Once the nubs are aligned with the notches, the extraction toolcan be separated from the device by guiding the nubs along thevertically aligned notches in a direction away from the orthopedicdevice. In this manner, the extraction tool and orthopedic device may beseparated.

Although the present invention has been discussed in considerable detailwith reference to certain preferred embodiments, other embodiments arepossible. Therefore, the scope of the appended claims should not belimited to the description of preferred embodiments contained in thisdisclosure.

What is claimed is:
 1. A method of preparing a defect at a treatmentsite on a subchondral bone to repair an anatomical joint and amelioratea joint condition, the method comprising: surgically accessing thetreatment site; accessing a sizing instrument, the sizing instrumenthaving a proximal end, a distal end, and a cylindrical member disposedbetween the proximal end and the distal end, the cylindrical memberhaving a lumen for receiving a guidewire; centrally positioning thedistal end of the sizing instrument over the defect at the treatmentsite on the subchondral bone; the distal end having concentric ringswith each ring having a known diameter; measuring a diameter of thedefect by comparing the defect diameter with the closest correspondingknown diameter on the sizing instrument; inserting the guidewire throughthe lumen of the cylindrical member while the distal end of the sizinginstrument is centrally positioned over the defect; contacting thesubchondral bone with a distal end of the guidewire; marking the centerof the defect by reversibly attaching the guidewire to the subchondralbone; removing the sizing instrument over the guidewire; selecting acountersink instrument having a diameter substantially matching themeasured diameter of the defect; positioning the countersink instrumentover the guidewire; simultaneously rotating and lowering the countersinkinstrument to engage a soft tissue and the subchondral bone; penetratingthe subchondral bone with the countersink instrument to form a hole, thehole having a first depth; removing the countersink instrument over theguidewire; positioning a cannulated drill over the guidewire; removingan inner circular portion of the subchondral bone while preserving acentral post of subchondral bone in a substantially undisturbed nativestate by simultaneously rotating and lowering the cannulated drill intoa center of the hole, the inner circular portion having a second depth;removing the cannulated drill over the guidewire; placing an implantableorthopedic device in the hole over a top of the central post; whereinthe central post is accepted by a hollow central column of theimplantable orthopedic device when implanted; securing the implantableorthopedic device into the hole using a driver instrument; removing thedriver instrument; detaching the guidewire from the subchondral bone;and removing the guidewire.
 2. The method of claim 1, furthercomprising: providing an inflatable envelope; inserting the inflatableenvelope into the anatomical joint in a collapsed position; and at leastpartially expanding the inflatable envelope to an inflated position soas to cause a surrounding tissue to be displaced by an inflationpressure.
 3. The method of claim 1, wherein at least one of: the firstdepth allows placement of the implantable orthopedic device at asubstantially flush orientation with a surface of the subchondral bone;or the second depth promotes blood flow around the top and each of aside of the central post so as to facilitate repair of the anatomicaljoint at the treatment site.
 4. The method of claim 1, whereinpreserving the central post of subchondral bone in a substantiallyundisturbed state provides structural integrity to the treatment siteand facilitates repair of the anatomical joint.
 5. The method of claim1, wherein at least one of: the inner circular portion has a diameterless than or equal to the diameter of the hole and the inner circularportion has a diameter larger than a diameter of a wall of theimplantable orthopedic device; or the second depth is sufficient toallow placement of the implantable orthopedic device.
 6. The method ofclaim 1, wherein the countersink instrument comprises two or moreblades, wherein the blades are equally spaced apart from one another. 7.The method of claim 6, wherein the blades are arranged circumferentiallyabout a central axis.
 8. The method of claim 6, wherein the countersinkinstrument comprises four blades, each blade oriented at 180 degreesrelative to the adjacent blade.
 9. The method of claim 6, wherein eachblade is configured with a radius of curvature that substantiallymirrors a radius of curvature of the subchondral bone at the treatmentsite, wherein the radius of curvature of the subchondral bone at thetreatment site may be convex, concave, or flat.
 10. The method of claim1, wherein the cannulated drill comprises two or more prongs, whereineach prong is equally spaced apart from one another.
 11. The method ofclaim 10, wherein the cannulated drill comprises three prongs, theprongs configured to debride and clear bone away during use to preservea porosity of the bone, minimize tissue trauma, encourage bleeding, andpromote healing at the treatment site.
 12. The method of claim 11,wherein the bleeding includes laminar blood flow, turbulent blood flow,capillary blood flow, or percolatory blood flow.
 13. The method of claim1, wherein securing the implantable orthopedic device in the hole usingthe driver instrument further comprises: engaging a distal end of thedriver instrument with a joint-ward end of a first section of theimplantable orthopedic device; and screwing the implantable orthopedicdevice into the hole.
 14. The method of claim 1, further comprising:creating one or more vascular channels in the subchondral bone at thetreatment site to facilitate bleeding.
 15. The method of claim 14,wherein at least one of: the vascular channels are created after theremoving the countersink instrument over the guidewire; or the vascularchannels are created via drilling, reaming, tapping, boring, or poking.16. The method of claim 1, wherein at least one of: the second depth isgreater than a length of the implantable orthopedic device; a distal endof the driver instrument reversibly engages a joint-ward end of theimplantable orthopedic device to move the implantable orthopedic deviceinto the hole; or the treatment site is surgically accessed using aretrograde, antegrade, or peripheral insertion technique.
 17. The methodof claim 1, wherein the placing of the implantable orthopedic deviceinto the hole further comprises: locking the implantable orthopedicdevice in the hole at a depth where a joint-ward end of the implantableorthopedic device is substantially flush with a surface of thesubchondral bone.
 18. The method of claim 17, wherein the implantableorthopedic device is locked in the hole via a morse locking taperedconnection.
 19. The method of claim 1, further comprising: covering theimplantable orthopedic device with a protective sleeve before theimplantable orthopedic device is introduced into a patient having thetreatment site; and removing the protective sleeve before theimplantable orthopedic device is positioned in the hole over the top ofthe central post.